Trial Condition(s):
Erectile Dysfunction
Evaluation of the safety and efficacy of Vardenafil in subjects with Erectile Dysfunction
Bayer Identifier:
100541
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
Inclusion Criteria
- Men >/= 18 years of age, - ED 6 months or longer - Stable sexual relationship for > 6 month.
Exclusion Criteria
- Primary hypoactive sexual desire - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month - Nitrate therapy - Other exclusion criteria apply according to the Summary of Product Characteristics
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Australia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, multi-centre, study to investigate the safety, tolerability and efficacy of flexible doses of vardenafil given on demand in males with erectile dysfunction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- International Index of Erectile Function - Erectile Function DomainTimeframe: 12 weeks
Secondary Outcome
- Sexual Encounter Profile Question 2 and 3Timeframe: 12 weeks
- Global Assessment QuestionTimeframe: 12 weeks
- Other diary based variablesTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
Copyright © Bayer
Powered by
